Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03631199 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 673
- Enrollment target
NCT03631199: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT03631199 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 673 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03631199, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 673 participants
- Enrollment target
Study Summary
This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.
Primary Outcome
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Interventions
- DRUG pembrolizumab
- DRUG cisplatin
- DRUG carboplatin
- DRUG canakinumab
- DRUG canakinumab-matching placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 673 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2026-01-26 |
| Phase | Phase 3 |
Why NCT03631199 stopped before completion
NCT03631199 is an interventional study that assigns participants to a tested intervention. The registered 673 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which pembrolizumab is the first listed.
NCT03631199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03631199 about?
NCT03631199 is a clinical study titled "Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects". This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.
What is the current status of trial NCT03631199?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 673 participants. The study started on 2018-12-21. Estimated completion is 2026-01-26.
What interventions are being tested in trial NCT03631199?
The interventions under investigation include: pembrolizumab (DRUG), cisplatin (DRUG), carboplatin (DRUG), canakinumab (DRUG), canakinumab-matching placebo (DRUG).
Who is sponsoring clinical trial NCT03631199?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03631199's enrollment target sits among peer trials
673 544th of 2000 higher than 1,457 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06335381 · 674 participants · NA
MOMs Chat and Care Study
- NCT06757634 · 674 participants · Phase 3
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
- NCT05452031 · 672 participants · NA
A Dyadic Sleep Health Approach for Persons With Alzheimer's Disease and Caregivers
- NCT05493254 · 672 participants · NA
Enhancing Smoking Cessation Via Telehealth Options in Primary Care
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI